Desmotabs Melt 240 micrograms oral lyophilisate

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

DESMOPRESSIN ACETATE

可用日期:

Ferring Ireland Ltd

ATC代码:

H01BA; H01BA02

INN（国际名称）:

DESMOPRESSIN ACETATE

剂量:

240 microgram(s)

药物剂型:

Oral lyophilisate

处方类型:

Product subject to prescription which may be renewed (B)

治疗领域:

Vasopressin and analogues; desmopressin

授权状态:

Marketed

授权日期:

2005-09-30

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE USER
DESMOTABS MELT 60 MICROGRAMS ORAL LYOPHILISATE
DESMOTABS MELT 120 MICROGRAMS ORAL LYOPHILISATE
DESMOTABS MELT 240 MICROGRAMS ORAL LYOPHILISATE
Desmopressin (as acetate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU
• Keep this leaflet. You may need to use it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on
to others. It may harm
them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist.
This includes any possible side
effects not listed in this leaflet. See section 4.
IN THIS LEAFLET:
1. What Desmotabs Melt is and what it is used for
2. What you need to know before you take Desmotabs Melt
3. How to take Desmotabs Melt
4. Possible side effects
5. How to store Desmotabs Melt
6. Contents of the pack and other information
1. WHAT DESMOTABS MELT IS AND WHAT IT IS USED FOR:
Desmotabs Melt is for sublingual use (placed under the tongue).
Desmotabs Melt contain
desmopressin (as acetate), an antidiuretic that reduces urine
production.
Desmotabs Melt is used to treat:
• DIABETES INSIPIDUS
(extreme thirst and the continuous production of large volumes of
dilute
urine). IMPORTANT: this should not be confused with diabetes mellitus
(sugar diabetes)
• PRIMARY NOCTURNAL ENURESIS
(bedwetting from the age of 5)
• NOCTURIA
in adults up to 65 years (night time urine production exceeding
bladder capacity)
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DESMOTABS MELT
DO NOT TAKE DESMOTABS MELT

if you are allergic to desmopressin or any of the other ingredients of
this medicine,
listed in section 6

if you have a serious heart or kidney disease

if you are taking diuretics (water tablets)

if you drink unusually large quantities of fluids, including alcohol

for Primary Nocturnal Enuresis and Nocturia: these tablets should not
be used if

产品特点

Health Products Regulatory Authority
30 November 2020
CRN00C22R
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Desmotabs Melt 240 micrograms oral lyophilisate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each unit contains 240 micrograms desmopressin (free base), present as
desmopressin acetate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral lyophilisate
White, round, oral lyophilisate marked with three drop shaped figures
on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1.
For the diagnosis and treatment of cranial diabetes insipidus
including post- hypophysectomy polyuria/polydipsia and for
the treatment of primary nocturnal enuresis in patients (from 5 to 65
years of age) with normal ability to concentrate urine.
2.
Desmotabs Melt is indicated for the symptomatic treatment of nocturia
in adults up to 65 years only, associated with
nocturnal polyuria, i.e. nocturnal urine production exceeding bladder
capacity.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
GENERAL
Method of administration: Desmotabs Melt is placed under the tongue
where it dissolves without the need for water.
Effect of food: Food intake may reduce the intensity and duration of
the antidiuretic effect at low doses of desmopressin (see
section 4.5).
In the event of signs or symptoms of water retention and /or
hyponatraemia (headache, nausea/vomiting, weight gain, and, in
severe cases, convulsions) treatment should be interrupted until the
patient has fully recovered. When restarting treatment
strict fluid restriction should be enforced (see section 4.4).
If adequate clinical effect is not achieved within 4 weeks following
appropriate dose titration the medication should be
discontinued.
INDICATION SPECIFIC
_Central Diabetes Insipidus:_
Dosage is individual in diabetes insipidus but the total daily
sublingual dose normally lies in the range of 120 micrograms to
720 micrograms. A suitable starting dose in adults and children is 60
micrograms three times daily administered sublingu